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Prevention av Autoimmunitet Med Laktobaciller (PAL)

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ClinicalTrials.gov Identifier: NCT04014660
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Lund University

Brief Summary:
The incidence of autoimmune diseases (celiac disease, type 1 diabetes, thyroid disease) have increased over the past 30 years. Although most autoimmune diseases have a strong link to different risk genes, the rapid increase is thought to be due to changes in environmental factors. There is currently no cure for autoimmune diseases, but the treatment is lifelong and either involves suppressing the inflammation and / or substituting the organs that are affected to maintain vital functions. Being able to predict who is affected and identifying factors that trigger autoimmunity is necessary for developing new treatment methods that prevent the occurrence of autoimmune diseases. The bacterial flora's composition in the gut can affect both the intestinal barrier properties and the immune system's response to various dietary components. An adverse composition of the intestinal flora can activate parts of the immune system that are involved in chronic inflammation in celiac disease and inflammatory bowel disease. Probiotics are defined as living microorganisms which, when ingested in sufficient amounts, produce a health effect (FAO / WHO). The aim of the study is to investigate whether a daily oral intake of a mixture of L.paracasei and L.plantarum can affect the autoimmune process in children who are screened positive for any of the autoantibodies associated with development of celiac disease, type 1 diabetes and / or thyroid disease. Our hypothesis is that lactobacilli can directly regulate the autoimmune process in the small intestinal mucosa by stimulating regulatory T-cells, but also by affecting the permeability of the small intestinal mucosa by of antigen that stimulates specific T-cells.

Condition or disease Intervention/treatment Phase
Celiac Disease in Children Type 1 Diabetes Thyroid Dietary Supplement: Probiotic Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Prevention av Autoimmunitet Med Laktobaciller (in English; Prevention of Autoimmunity With Lactobacilli)
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Probiotic group
The participants in this group are provided with a dietary supplement (capsules) containing freeze dried bacteria (active lactobacilli culture) mixed with corn starch, for daily intake (1 capsule per day).
Dietary Supplement: Probiotic
The probiotic product consists of two different bacterial strains, L.plantarum Heal 9 and L.paracasei 8700:2

Placebo Comparator: Placebo group
The participants in this group are provided with a dietary supplement (capsules) containing corn starch only, for daily intake (1 capsule per day).
Dietary Supplement: Placebo
The placebo supplement consists of corn starch only.




Primary Outcome Measures :
  1. Autoimmunity [ Time Frame: 12 months ]
    To study levels of auto-antibodies (tTGA, GADA, IA-2, IAA, ZnT8a, TPOA) genetically at-risk children. (Blood sample will be analyzed for auto-antibodies (tTGA, GADA, IA-2A, IAA, Zn-T8A, and TPOA)



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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Screened persistent positive for any of the auto-antibodies associated with celiac disease (tTGa), type 1 diabetes (IAA, GADA, IA-2A, Zn-T8) and/or thyroid disease (TPOA)

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014660


Contacts
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Contact: Carin Andrén Aronsson, PhD +46 40 391113 carin.andren_aronsson@med.lu.se

Locations
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Sweden
Clinical Research Center (CRC), Bldng 60:11 Recruiting
Malmö, Sweden, 20502
Contact: Carin Andrén Aronsson, PhD    +46 40391113    carin.andren_aronsson@med.lu.se   
Sponsors and Collaborators
Lund University
Investigators
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Principal Investigator: Daniel Agardh, PhD Dep Clinical Sciences, Lund University
Publications of Results:

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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT04014660    
Other Study ID Numbers: 2019-02322
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University:
celiac disease autoimmunity
islet autoimmunity
auto-antibodies
Additional relevant MeSH terms:
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Celiac Disease
Metabolic Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases